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Capturing the immunotherapy opportunity in myeloid blood cancers

In the fourth quarter of 2025, Mendus presented continued positive long-term survival data of the ADVANCE II trial in acute myeloid leukemia (AML) at the ASH 2025 conference.

The data support the updated clinical strategy to position vididencel broadly as a first-line post-remission therapy in AML. Mendus will also develop vididencel in chronic myeloid leukemia (CML), with two clinical trials being prepared to start in 2026. Finally, positive 2-year follow-up data from the ALISON Phase 1 trial in high-risk ovarian cancer were reported in December, positioning vididencel as potential combination treatment with other therapeutic modalities in this indication.  

 

Erik Manting, CEO

Myeloid blood cancers like AML and CML are vulnerable to attack by the immune system. This principle has been shown extensively by hematopoietic stem cell transplantation (HSCT), a potentially curative but high-risk procedure associated with mortality and severe side effects including graft-versus-host disease. Mendus is developing vididencel as an active immunotherapy to control residual disease and achieve durable clinical remissions in AML, without harming health or quality of life. This is particularly relevant for patients unable to undergo HSCT.

At the ASH conference, Mendus presented updated results from the ADVANCE II Phase 2 trial, a multi-center European trial which continued to demonstrate robust relapse-free and overall survival benefit in a high-risk AML population, based on the presence of persistent measurable residual disease (MRD) following intensive chemotherapy (IC). At a median follow-up of 55 months, 13 out of 20 patients treated with vididencel were still alive, with 8 patients having passed 5-year follow-up and an estimated 5-year survival of 63%, versus less than 30% with standard of care.

Vididencel is currently being studied in the ongoing Australian AMLM22-CADENCE randomized Phase 2b trial in combination with oral azacitidine to improve relapse-free and overall survival following IC independent of MRD status. The study is on track to enroll the first 20 patients in the first half of 2026. To treat AML patients classified as “unfit” for standard IC, a less intensive therapy comprising venetoclax combined with azacitidine (Ven+Aza) has been approved. Increasing clinical evidence also supports the expanding use of Ven+Aza to treat newly diagnosed AML in “fit” adults. To adapt to this evolution of first line treatment, vididencel will be studied in combination with Ven+Aza in the Phase 1b DIVA trial, which is expected to start mid-2026. The results from the CADENCE and DIVA trials, combined with the evolving treatment landscape in AML will determine the go-to-market strategy for vididencel in AML in 2027.

CML, unlike AML, is a chronic disease that can be effectively controlled with targeted therapy based on tyrosine kinase inhibitors (TKIs). Thanks to the TKI success, overall survival expectations for chronic-phase (CP) CML patients today are close to the general population. However, the impact on quality of life and costs associated with continuous TKI treatment have led to a new frontier in the treatment of CP-CML, which is to accomplish treatment-free remissions (TFR). Like in AML, HSCT is curative in CML, but due to the treatment-related side effects it has been largely abandoned since the introduction of TKIs. Based on its strong safety profile, vididencel may support TFR in CP-CML by stimulating immune control over residual disease. To position vididencel in CP-CML, the VITAL-CML Phase 1 trial is expected to start in the first half of 2026 and will focus on patients that have a suboptimal response to TKIs. Subject to initial positive safety and tolerability data from the VITAL-CML trial, the VITAL-TFR2 Phase 2a trial is expected to commence towards the end of the year, to evaluate vididencel in the second TFR setting, for CP-CML patients with a previously failed TFR attempt.

In its earlier-stage pipeline, Mendus reported positive 2-year follow-up data from the ALISON Phase 1 trial in high-grade serous ovarian cancer. The data confirmed that vididencel-induced tumor-directed immune responses were associated with prolonged progression-free survival. No product-related serious side effects were observed, positioning vididencel as a safe immunotherapy that can be combined with other therapeutic modalities.

In the fourth quarter of 2025, Mendus completed a financing round comprising a SEK 52.5M directed placement, combined with a loan facility of up to SEK 50M. The company also finalized a corporate reorganization and reduction of its staff, including downsizing the company’s executive management team. The cost savings realized by the corporate reorganization are estimated to offset the extra clinical trial costs anticipated for 2026.

With multiple key milestones anticipated in 2026, including the first clinical data in CML, we look forward to an eventful year ahead. We wish to express gratitude to all of our stakeholders, including the clinical community and participants in our trials, for their continued commitment and support.

Erik Manting, Ph.D.
Chief Executive Officer

 

*Published on February 11, 2026